US9017317B2

US9017317B2 - Refrigerant supply system for cryotherapy including refrigerant recompression and associated devices, systems, and methods

Info

Publication number: US9017317B2
Application number: US13/707,385
Authority: US
Inventors: Eric Ryba; Gary Kelly
Original assignee: Medtronic Ardian Luxembourg SARL
Current assignee: Medtronic Ardian Luxembourg SARL
Priority date: 2012-12-06
Filing date: 2012-12-06
Publication date: 2015-04-28
Also published as: WO2014089237A2; EP2928422A2; US20140163538A1; WO2014089237A3; EP2928422B1

Abstract

Cryotherapeutic systems configured for refrigerant recompression and associated devices, systems, and methods are disclosed herein. A cryotherapeutic system configured in accordance with a particular embodiment includes a high-pressure line, a low-pressure line, a recompression unit, and a cryo-catheter. The recompression unit increases the pressure of refrigerant from the low-pressure line to the high-pressure line to a treatment pressure sufficient for cryogenic alteration of tissue. The high-pressure line and the low-pressure line include, respectively, a first connector and a second connector. The cryo-catheter includes a shaft, a supply lumen in the shaft that is coupled to the first connector, an exhaust lumen in the shaft that is coupled to the second connector, and a cryo-applicator attached to the shaft having a cooling chamber configured to receive refrigerant from the supply lumen and to return refrigerant via the exhaust lumen to the low-pressure line.

Description

TECHNICAL FIELD

The present technology is related to cryotherapy (e.g., cryoablation). In particular, some embodiments are related to cryotherapeutic systems configured for refrigerant recompression, refrigerant supply devices for cryotherapeutic systems, and cryotherapeutic methods including refrigerant recompression, among other devices, systems, and methods useful in the context of cryotherapy.

BACKGROUND

Many cryotherapeutic procedures include introducing a cryo-catheter into a patient (e.g., into the vasculature of a patient) and cooling a cryo-applicator of the cryo-catheter using refrigerant. In some cases, refrigerant introduced into the cryo-catheter is chilled and circulated through the cryo-applicator without expanding significantly. For example, the cryo-catheter can be thermally insulated proximal to the cryo-applicator such that chilled refrigerant circulated through the cryo-catheter does not readily absorb heat from nearby tissue until it reaches the cryo-applicator. In other cases, refrigerant, which can be chilled or not chilled, expands significantly within the cryo-catheter and drops in temperature and/or absorbs heat from nearby tissue due to the Joule-Thomson effect alone or in combination with increasing latent heat. For example, refrigerant can enter the cryo-catheter partially or entirely in liquid phase at high pressure, expand and/or vaporize by passing through an orifice within the cryo-applicator, and then exit the cryo-catheter in gas phase at low pressure. Cooling via refrigerant expansion can be particularly useful in relatively long and narrow cryo-catheters (e.g., most intravascular cryo-catheters). In such cryo-catheters, for example, refrigerant cooling potential in the form of high refrigerant pressure can usually be maintained more readily than refrigerant cooling potential in the form of low refrigerant temperature while refrigerant is en route to a distal cryo-applicator.

In conventional cryotherapeutic systems configured for cooling by refrigerant expansion, resulting expanded refrigerant is typically exhausted to the atmosphere or collected for disposal. For example, a conventional cryotherapeutic system can be configured to be connected to a hospital scavenging system that transports expanded refrigerant to a centralized location for disposal. Both releasing expanded refrigerant into the atmosphere and transporting expanded refrigerant to a centralized location deplete the supply of refrigerant available to the system. Accordingly, conventional cryotherapeutic systems are typically configured to be connected to refrigerant supply tanks that must frequently be replaced or recharged. Replacing or recharging refrigerant supply tanks, however, can be logistically challenging and costly. Furthermore, although larger refrigerant supply tanks often require replacement or recharging less frequently than smaller refrigerant supply tanks, larger refrigerant supply tanks are also typically more obtrusive and cumbersome to handle than smaller refrigerant supply tanks.

Conventional cryotherapeutic systems are usually only compatible with certain types of refrigerants. For example, many conventional cryotherapeutic systems are configured for use with nitrous oxide, which can be released into the atmosphere or collected for disposal with little or no concern for toxicity or environmental impact. While nitrous oxide is a useful refrigerant, other refrigerants can have more advantageous thermodynamic properties (e.g., greater latent heats of vaporization) than nitrous oxide. These other refrigerants, however, are potentially more harmful to the environment than nitrous oxide. Intentionally and non-incidentally releasing and/or disposing of such refrigerants is, in many cases, prohibited by regulations, inconsistent with accepted medical protocols, or both. Thus, many potentially useful types of refrigerants are not available for use in conventional cryotherapeutic systems configured to release expanded refrigerant into the atmosphere or to collect expanded refrigerant for disposal. This can limit the performance of such systems.

For the reasons stated above and for other reasons, whether or not expressly disclosed herein, there is a need for innovation in the field of cryotherapy. For example, there is a need for innovation with regard to devices, systems, and methods that reduce the need for replacing or recharging refrigerant supply tanks, that facilitate the use of additional types of refrigerants, and/or that have other advantages relative to conventional devices, systems, and/or methods.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. For ease of reference, throughout this disclosure identical reference numbers may be used to identify identical or at least generally similar or analogous components or features.

FIGS. 1 and 2 are partially schematic diagrams illustrating cryotherapeutic systems in accordance with embodiments of the present technology.

FIG. 3 is an enlarged, partially schematic diagram illustrating a recompression unit of the cryotherapeutic system shown in FIG. 2.

FIGS. 4-7 are enlarged, partially schematic diagrams illustrating recompression units in accordance with additional embodiments of the present technology.

FIG. 8 is an enlarged, partially schematic diagram illustrating an exhaust vessel of the cryotherapeutic system shown in FIG. 2.

FIGS. 9 and 10 are enlarged, partially schematic diagrams illustrating exhaust vessels in accordance with additional embodiments of the present technology.

FIG. 11 is a block diagram illustrating stages during operation of the cryotherapeutic system shown in FIG. 2 in accordance with an embodiment of the present technology.

DETAILED DESCRIPTION

Specific details of several embodiments of the present technology are described herein with reference to FIGS. 1-11. Although many of the embodiments are described herein with respect to devices, systems, and methods for intravascular cryotherapeutic neuromodulation, other applications and other embodiments in addition to those described herein are within the scope of the present technology. For example, some embodiments may be useful for intraluminal cryotherapy, extravascular cryotherapy, or intravascular cryotherapy for a purpose other than neuromodulation. It should be noted that some embodiments of the present technology can have different configurations and/or procedures than those shown or described herein. Moreover, a person of ordinary skill in the art will understand that some embodiments of the present technology can have features, components, and/or operations in addition to those shown or described herein and that these and other embodiments can be without several of the features, components, and/or operations shown or described herein without deviating from the present technology.

Cryotherapeutic systems and associated devices, systems, and methods configured in accordance with embodiments of the present technology can have one or more advantageous features relative to the prior art. For example, a cryotherapeutic system in accordance with an embodiment of the present technology can be configured to reuse refrigerant rather than releasing refrigerant into the atmosphere or collecting refrigerant for disposal. The cryotherapeutic system can be configured to collect refrigerant from an exhaust lumen of a cryo-catheter, to recompress collected refrigerant, and to supply recompressed refrigerant to a supply lumen of the cryo-catheter or to the supply lumen of another cryo-catheter. In some embodiments, recompressing collected refrigerant includes condensing collected refrigerant such that recompressed refrigerant can be supplied to the supply lumen at least partially in liquid phase. Since refrigerant within the system is reused instead of released into the atmosphere or otherwise discarded outside of the system, the need to replace or recharge a supply tank can be mostly or entirely eliminated. Thus, long-term operation of the system can be less logistically challenging and/or less costly than long-term operation of many conventional cryotherapeutic systems. Furthermore, in some cases, since refrigerant can be generally contained within the system, the system can be used with types of refrigerants that are potentially more harmful to the environment than nitrous oxide, but that also have more advantageous thermodynamic properties than nitrous oxide. For example, in addition to nitrous oxide, the system can be used with suitable hydrofluorocarbons (e.g., difluoromethane), among other types of refrigerants.

FIG. 1 is a partially schematic diagram illustrating a cryotherapeutic system 100 in accordance with an embodiment of the present technology. The system 100 can include a cryo-catheter 102 removably connected to a console 104. Within the console 104, the system 100 can include a high-pressure line 106, a low-pressure line 108, and a recompression unit 110 therebetween. In some embodiments, the low-pressure line 108 includes an exhaust vessel 111 configured to contain exhausted refrigerant from the cryo catheter 102. The exhaust vessel 111 can have a volume, for example, from about 3 liters to about 20 liters, from about 5 liters to about 15 liters, or within another suitable range. For example, the volume can be about 10 liters. Instead of or in addition to the exhaust vessel 111, the system 100 can include one or more other components configured for storing refrigerant when the refrigerant is not in use. For example, the high-pressure line 106 can include a supply vessel (not shown) configured to store compressed refrigerant (e.g., liquid refrigerant) downstream from the recompression unit 110.

The high-pressure line 106 can be configured to be operably connected to a supply lumen 112 of the cryo-catheter 102. Similarly, the low-pressure line 108 can be configured to be operably connected to an exhaust lumen 114 of the cryo-catheter 102. For example, the high-pressure line 106 and the low-pressure line 108 can include, respectively, a first coupler 116 and a second coupler 118 accessible from outside the console 104. The first coupler 116 can be configured to cooperatively engage a third coupler 120 of the supply lumen 112. The second coupler 118 can be configured to cooperatively engage a fourth coupler 122 of the exhaust lumen 114. The first and

third couplers

116, 120 and the second and

fourth couplers

118, 122 can be threaded, compression fit, barbed, or have other suitable cooperative features configured to form releasable fluidic connections. In other embodiments, the cryo-catheter 102 can be permanently connected to the console 104. For example, the first, second, third, and

fourth couplers

116, 118, 120, 122 can be eliminated, and the high-pressure line 106 and the low-pressure line 108 can be integral extensions of the supply lumen 112 and the exhaust lumen 114, respectively. In still other embodiments, the first, second, third, and

fourth couplers

116, 118, 120, 122 can have other suitable locations within the system 100 (e.g., separate from the console 104).

The cryo-catheter 102 can include an elongated shaft 124 having a proximal end portion 124 a, a distal end portion 124 b, and a main portion 124 c therebetween. At or near the distal end portion 124 b, the cryo-catheter 102 can include a cryo-applicator 126 attached to the shaft 124. The cryo-applicator 126 can include a cooling chamber 128 configured to receive refrigerant from the high-pressure line 106 via the supply lumen 112 and to return refrigerant to the low-pressure line 108 via the exhaust lumen 114. In some embodiments, the cooling chamber 128 is a balloon configured to compliantly, non-compliantly, and/or semi-compliantly expand when refrigerant is present within the cooling chamber 128. For example, the cooling chamber 128 can be configured to circumferentially expand to span the cross-sectional area of a blood vessel (e.g., a renal artery). Therapeutically effective cooling can be applied to a wall of the blood vessel via the cryo-applicator 126 (e.g., to cause neuromodulation or another desirable cryotherapeutic effect). In other embodiments, the cryo-applicator 126 can be an integral portion of the shaft 124 and/or the cooling chamber 128 can be non-expandable.

The supply lumen 112 and the exhaust lumen 114 can be positioned at least partially within the shaft 124. For example, the supply lumen 112 can extend from the third coupler 120 to the proximal end portion 124 a, along the main portion 124 c, and to an expansion orifice 130 of the cryo-applicator 126 within the cooling chamber 128. Similarly, the exhaust lumen 114 can extend from the fourth coupler 122 to the proximal end portion 124 a, along the main portion 124 c, and to an exhaust opening 132 of the cryo-applicator 126 within the cooling chamber 128. Refrigerant at relatively high pressure can flow from the high-pressure line 106, through the supply lumen 112, and to the expansion orifice 130, and then can expand within the cooling chamber 128 to cool the cryo-applicator 126. For example, refrigerant within the supply lumen 112 proximal to the expansion orifice 130 can be at least partially in liquid phase and vaporize at the expansion orifice 130 or elsewhere within the cooling chamber 128 to cool the cryo-applicator 126 by absorbing latent heat. In some cases, additional cooling can occur without phase change due to the Joule-Thomson effect. Expanded refrigerant at relatively low pressure can exit the cooling chamber 128 through the exhaust opening 132 and flow through the exhaust lumen 114 to the low-pressure line 108.

The console 104 can be configured to regulate the flow of refrigerant into the supply lumen 112 and/or out of the exhaust lumen 114, both of which can affect cooling activity within the cryo-applicator 126. In some embodiments, the high-pressure line 106 includes a supply valve 134 configured to open and close and thereby start and stop the flow of refrigerant toward the supply lumen 112. Similarly, the low-pressure line 108 can include an exhaust valve 136 configured to open and close and thereby start and stop the flow of refrigerant toward the recompression unit 110. The supply valve 134 and the exhaust valve 136 can also be configured to be partially open so as to vary the flow of refrigerant incrementally and/or infinitely within suitable ranges. In many cases, however, it can be advantageous to control the flow of refrigerant primarily or entirely via operation of the recompression unit 110. The recompression unit 110 can be operably connected to the high-pressure line 106 and the low-pressure line 108 and configured to increase the pressure of refrigerant moving from the low-pressure line 108 to the high-pressure line 106. In some cases, refrigerant moving through the recompression unit 110 at least partially condenses. In other cases, refrigerant moving through the recompression unit 110 can enter and exit the recompression unit 110 in the gas phase.

The high-pressure line 106, the low-pressure line 108, and the recompression unit 110 can be configured to define a portion of a closed loop when the high-pressure line 106 is operably connected to the supply lumen 112 and the low-pressure line 108 is operably connected to the exhaust lumen 114. The closed loop, for example, can extend between the recompression unit 110 and the cooling chamber 128 with a high-pressure portion on one side of the closed loop and a low-pressure portion on the other side of the closed loop. The high-pressure portion can include the high-pressure line 106 and the supply lumen 112, and the low-pressure portion can include the low-pressure line 108 and the exhaust lumen 114. In some embodiments, the high-pressure line 106, the supply lumen 112, and any other suitable components within the high-pressure portion are configured to carry liquid refrigerant. Similarly, the low-pressure line 108, the exhaust lumen 114, and any other suitable components within the low-pressure portion can be configured to carry gaseous refrigerant. For example, the cross-sectional area of refrigerant-carrying components along the low-pressure portion can be greater than the cross-sectional area of refrigerant-carrying components along the high-pressure portion to accommodate the greater volume of gaseous refrigerant relative to liquid refrigerant.

The high-pressure line 106, the low-pressure line 108, and the recompression unit 110 can be configured to contain a first volume of refrigerant. In some embodiments, the system 100 is configured to replenish the first volume of refrigerant to account for refrigerant loss (e.g., incidental refrigerant loss) from the first volume of refrigerant. For example, the system 100 can include a make-up reservoir 138 operably connected to the high-pressure line 106. The make-up reservoir 138 can be configured to contain a second volume of refrigerant sufficient to replace refrigerant loss (e.g., incidental refrigerant loss) from the first volume of refrigerant. Such refrigerant loss can occur, for example, when the supply lumen 112 is disconnected from the high-pressure line 106, when the exhaust lumen 114 is disconnected from the low-pressure line 108, or both (e.g., during exchange of the cryo-catheter 102). In some embodiments, the second volume of refrigerant is sufficient to replace refrigerant loss during use of the system 100 for a number of treatments (e.g., a number of cryotherapeutic renal neuromodulation treatments) from about 20 to about 1000, from about 40 to about 500, from about 60 to about 300, or within another suitable range. For example, the second volume of refrigerant can be sufficient to replace refrigerant loss during use of the system 100 for about 100 treatments.

The system 100 can include a make-up valve 140 operably connected to the closed loop at the high-pressure line 106. In other embodiments, the make-up reservoir 138 and the make-up valve 140 can be connected to the closed loop at another suitable point (e.g., at the low-pressure line 108 or at the recompression unit 110). The make-up valve 140 can be configured to regulate the flow of refrigerant from the second volume of refrigerant toward the first volume of refrigerant. For example, the make-up valve 140 can open as needed to replenish the first volume of refrigerant in response to refrigerant loss. Less frequently, the second volume of refrigerant can be replenished via a make-up port 142 of the system 100, which can be accessible from outside the console 104. In some cases, the console 104 alone or together with the cryo-catheter 102 can be provided to a user pre-filled with a suitable refrigerant (e.g., nitrous oxide or a hydrofluorocarbon refrigerant). In other cases, a service technician can introduce an initial charge of refrigerant (e.g., via the make-up port 142) when the system 100 is first installed.

The system 100 can be configured for manual or automatic control. For example, the supply valve 134, the exhaust valve 136, and the make-up valve 140 can be operated manually or automatically. In some embodiments, the system 100 includes a user interface 144, one or more sensors 146, a controller 148, and communication lines 150 operably connecting the user interface 144 and the sensors 146 to the controller 148. The system 100 can further include one or more actuators 152 operably connected to the supply valve 134, the exhaust valve 136, and/or the make-up valve 140 individually. The actuators 152 and the recompression unit 110 can be operably connected to the controller 148 via the communication lines 150. In other embodiments, some or all of the communication lines 150 can be eliminated and the user interface 144, the sensors 146, the actuators 152, and/or the recompression unit 110 can be configured to communicate with the controller 148 wirelessly. The controller 148 can include a processor (not shown) and memory (also not shown) and can be programmed with instructions (e.g., non-transitory instructions) corresponding to one or more suitable control algorithms. For example, the controller 148 can be configured to receive input from the user interface 144 and/or the sensors 146, and to control the actuators 152 and/or the recompression unit 110 based on the input. Furthermore, the controller 148 can be configured to receive input from the user interface 144 and/or the sensors 146 and to generate a display at the user interface 144 based on the input.

The sensors 146 can be configured to measure pressure, volume, temperature, mass flow rate, and/or other suitable parameters of refrigerant at one or more positions within the system 100. For example, individual sensors 146 can be operably coupled to the high-pressure line 106 and/or the low-pressure line 108 and configured to measure and/or monitor the first volume of refrigerant. Similarly, a sensor 146 can be operably connected to the make-up reservoir 138 and configured to measure and/or monitor the second volume of refrigerant. The controller 148 can be configured to receive an indication of refrigerant loss from the first volume of refrigerant and to open the make-up valve 140 (e.g., via an actuator 152) in response to the indication. The make-up valve 140 can be opened in a controlled manner (e.g., for a selected period of time and/or to a selected extent) to permit refrigerant from the second volume of refrigerant to flow into the first volume of refrigerant in a quantity sufficient to compensate for the detected refrigerant loss from the first volume of refrigerant.

In some cases, it can be useful for refrigerant supplied to the cryo-catheter 102 to be free or nearly free of moisture (e.g., liquid water and/or water vapor), particulates, and/or other contaminants. Moisture, for example, can freeze within the cryo-catheter 102 into ice particles, which, along with other types of particulates, can interfere with operation of the cryo-catheter 102. The system 100 can include a filter 154 configured to remove moisture, particulates, or both during refrigerant reprocessing. The filter 154 can be positioned at a point along the high-pressure line 106, at a point along the low-pressure line 108, or at another suitable position within the system 100. When the filter 154 is positioned at a point along the high-pressure line 106, the filter 154 can be configured to filter liquid refrigerant (e.g., to remove liquid-entrained particulates and/or liquid water). Similarly, when the filter 154 is positioned at a point along the low-pressure line 108, the filter 154 can be configured to filter gaseous refrigerant (e.g., to remove gas-entrained particulates and/or water vapor). In some embodiments, the filter 154 includes a molecular sieve (e.g., activated alumina) having a suitable pore size (e.g., 3A or 4A) alone or in combination with one or more other filtering components (e.g., an adsorbent material or a polymer membrane).

The portion of the closed loop defined by the high-pressure line 106, the low-pressure line 108, and the recompression unit 110 can be generally impermeable to moisture and/or refrigerant. For example, components within the console 104 configured to contain refrigerant can be constructed from generally moisture-impermeable and/or refrigerant-impermeable materials, such as certain metals or fluorinated polymers (e.g., polychlorotrifluoroethylene), and/or connected using generally moisture-impermeable and/or refrigerant-impermeable connections (e.g., welded connections). In some cases, the moisture permeability and/or refrigerant permeability of the supply lumen 112, the exhaust lumen 114, and/or other refrigerant-carrying components of the cryo-catheter 102 can be greater than the moisture permeability and/or refrigerant permeability of refrigerant-carrying components of the system 100 located within the console 104. The materials, construction techniques, and/or other features of the refrigerant-carrying components of the cryo-catheter 102, for example, can be selected to favor greater flexibility, lower cost, greater compactness, and/or other attributes over low moisture and/or refrigerant permeability. In some cases, the supply lumen 112 and the exhaust lumen 114 can be made of a polyimide or another suitable material with non-negligible moisture and/or refrigerant permeability. In other cases, components of the cryo-catheter 102 configured to contain refrigerant can be constructed from generally moisture-impermeable and/or refrigerant-impermeable materials, such as certain composites (e.g., metal-lined polymers) or fluorinated polymers (e.g., polychlorotrifluoroethylene).

The console 104 can be relatively durable and the cryo-catheter 102 can be at least partially disposable (e.g., after one, two, three, or another suitable number of treatments). Furthermore, in some embodiments, the console 104 is configured to store generally all refrigerant within the system 100 when the system 100 is not in use (e.g., overnight and/or between treatments) and/or when the cryo-catheter 102 is being replaced. In contrast, the cryo-catheter 102 can be configured to carry circulating refrigerant during a treatment, but, in some cases, not to store refrigerant before and after the treatment. Accordingly, refrigerant loss from the system 100 and/or introduction of moisture into the system 100 due to the moisture and/or refrigerant permeability of refrigerant-carrying components of the cryo-catheter 102 can be relatively low. The filter 154 and the make-up reservoir 138 can be configured, respectively, to remove this moisture contamination and to replace this refrigerant loss in addition, respectively, to removing moisture contamination and replacing refrigerant loss that can occur when the cryo-catheter 102 is detached from the console 104.

In some embodiments, the system 100 is configured to reduce or eliminate refrigerant loss associated with detaching the cryo-catheter 102 from the console 104. For example, the system 100 can be configured such that a relatively small percentage of refrigerant within the system 100 (e.g., a percentage from about 0.01% to about 5%, from about 0.1% to about 5%, from about 1% to about 5%, or within another suitable range) is within the cryo-catheter 102 at any given time. Thus, even if all refrigerant within the cryo-catheter 102 is lost when the cryo-catheter 102 is detached from the console 104, the percentage of lost refrigerant relative to total refrigerant within the system 100 can be relatively small. Furthermore, the console 104 can be configured to evacuate remaining refrigerant within the cryo-catheter 102 after a treatment. For example, after a treatment, the supply valve 134 can be closed and the recompression unit 110 can be used to draw out remaining refrigerant within the cryo-catheter 102. After the remaining refrigerant has been mostly or entirely evacuated, the exhaust valve 136 can be closed. The third coupler 120 can then be detached from the first coupler 116, the fourth coupler 122 can be detached from the second coupler 118, and the cryo-catheter 102 can be discarded. The system 100 can be configured to reduce or eliminate the intake of air into the high-pressure line 106 and the low-pressure line 108 during this process. Since air contains water vapor, this can be useful to help maintain refrigerant within the system 100 free or nearly free of moisture.

FIG. 2 is a partially schematic diagram illustrating a cryotherapeutic system 200 in accordance with another embodiment of the present technology. The system 200 can include a cryo-catheter 202 removably connected to a console 204. Within the console 204, the system 200 can include a high-pressure line 206 having a supply vessel 208, and a low-pressure line 210 having an exhaust vessel 212. The supply vessel 208 and the exhaust vessel 212 can be configured to increase the refrigerant capacity of the high-pressure line 206 and the low-pressure line 210, respectively. This can be useful, for example, when the console 204 is configured to store the entirety or nearly the entirety of the refrigerant within the system 200 when the system 200 is not in use. In some embodiments, the high-pressure line 206 and the low-pressure line 210 have enhanced refrigerant capacity due to their length and/or diameter. For example, the high-pressure line 206 and the low-pressure line 210 can include serpentine portions (not shown) or coils (not shown) in place of or in addition to the supply vessel 208 and the exhaust vessel 212, respectively. In other embodiments, only the low-pressure line 210 can have enhanced refrigerant capacity and the system 200 can be configured to store refrigerant primarily before recompression. In still other embodiments, only the high-pressure line 206 can have enhanced refrigerant capacity and the system 200 can be configured to store refrigerant primarily after recompression.

With reference again to FIG. 2, the system 200 can include a high-pressure filter 214 at a suitable point along the high-pressure line 206 and a low-pressure filter 216 at a suitable point along the low-pressure line 210. The high-pressure filter 214 and the low-pressure filter 216 can be configured to remove moisture, particulates, or both during refrigerant reprocessing. In some embodiments, the high-pressure filter 214 and the low-pressure filter 216 are positioned upstream from the supply vessel 208 and the exhaust vessel 212, respectively. In other embodiments, the high-pressure filter 214 and the low-pressure filter 216 can be positioned downstream from the supply vessel 208 and the exhaust vessel 212, respectively.

The system 200 can include a controller 218 operably connected to the sensors 146, the actuators 152, the recompression unit 110, and the user interface 144. In some embodiments, the system 200 has more than one operational mode implemented by the controller 218 (e.g., in response to a user-initiated command from the user interface 144 and/or an indication from one or more of the sensors 146). For example, the system 200 can operate in a first mode during a treatment and in a second mode when the system 200 is not in use. In the first mode, the system 200 can be configured to at least partially deplete a supply of refrigerant within the supply vessel 208 by supplying refrigerant from the supply vessel 208 to the supply lumen 112. Also in the first mode, the system 200 can be configured to receive refrigerant within the exhaust vessel 212 from the exhaust lumen 114 via the low-pressure line 210. In the second mode, the system 200 can be configured to at least partially replenish the supply of refrigerant within the supply vessel 208 with refrigerant from the exhaust vessel 212 via the recompression unit 110.

The first and second modes can be non-concurrent. For example, the system 200 can be configured to operate in the second mode between treatments and/or overnight when operation of the recompression unit 110 is less likely to be disruptive (e.g., due noise associated with operation of the recompression unit 110). In other embodiments, the system 200 can be configured to supply high-pressure refrigerant to the supply lumen 112 and to recompress exhausted refrigerant from the exhaust lumen 114 concurrently. The exhaust vessel 212 can have a capacity sufficient to contain exhausted refrigerant from a limited number of treatments, such as one treatment or one cycle of treatments (e.g., from about one treatment to about 20 treatments or a number of treatments performed during a single day of treatments). When the supply vessel 208 is configured to contain liquid refrigerant and the exhaust vessel 212 is configured to contain gaseous refrigerant, it can be desirable to store surplus refrigerant (e.g., a quantity of refrigerant greater than a quantity of refrigerant used for one treatment or one cycle of treatments) within the supply vessel 208 rather than within the exhaust vessel 212. This can be the case, for example, because refrigerant can be unduly voluminous in the gas phase and relatively compact in the liquid phase. The system 200 can include a check valve 219 downstream from the recompression unit 110, which can be configured to reduce or prevent migration of refrigerant from the high-pressure line 206 to the low-pressure line 210 (e.g., when the recompression unit 110 is not active). In some embodiments, the check valve 219 is within the recompression unit 110. For example, a positive displacement pump (not shown) within the recompression unit 110 can serve as the check valve 219.

The system 200 can include a make-up reservoir 220 removably connectable to the closed loop (e.g., at the high-pressure line 206, at the low-pressure line 210, or at another suitable position within the closed loop). The make-up reservoir 220 can be disposable or configured to be disconnected from the high-pressure line 206 and refilled (e.g., at a remote facility) after it is depleted of refrigerant. The make-up reservoir 220 and high-pressure line 206 can include cooperative coupler valves 222. In some embodiments, the high-pressure line 206 includes another coupler valve 222 configured to releasably connect to a coupler valve 222 of the supply lumen 112. Similarly, the low-pressure line 210 can include a coupler valve 222 configured to releasably connect to a coupler valve 222 of the exhaust lumen 114. One or both members of one or more of the pairs of cooperative coupler valves 222 can be configured to automatically open when coupled to the corresponding member of the pair and to automatically close when not coupled to the corresponding member of the pair. Accordingly, some or all of the coupler valves 222 can act as check valves that reduce refrigerant loss and/or entry of air into components of the system 200 when the make-up reservoir 220 and/or the cryo-catheter 202 are partially or fully disconnected from the console 204. Thus, if the cryo-catheter 202 is temporarily disconnected from the console 204, the coupler valves 222 of the supply lumen 112 and the exhaust lumen 114 can reduce refrigerant loss from the cryo-catheter 202 even when remaining refrigerant within the cryo-catheter 202 is not displaced (e.g., as described above). This can be useful, for example, when the cryo-catheter 202 is reusable. The coupler valves 222 can be threaded, compression fit, barbed, or have other suitable cooperative features.

In some embodiments, the high-pressure line 206 includes a shutoff valve 224 and a pressure-regulated valve 226 configured to control the flow of refrigerant from the make-up reservoir 220 to the supply vessel 208 or to another portion of the high-pressure line 206 downstream from the make-up reservoir 220. In other embodiments, the make-up reservoir 220 can be removably connected to the system 200 at the low-pressure line 210, and the low-pressure line 210 can include the shutoff valve 224 and the pressure-regulated valve 226. With reference again to FIG. 2, the controller 218 can be configured to open the shutoff valve 224 after the system 200 at least partially replenishes the supply of refrigerant within the supply vessel 208 with refrigerant from the exhaust vessel 212 (e.g., while the system 200 is in the second operational mode). The pressure-regulated valve 226 can be configured to automatically open when a pressure within the supply vessel 208 is less than a threshold pressure. The threshold pressure can be selected to be at or near a pressure within the supply vessel 208 when the supply vessel 208 is full of refrigerant (e.g., when the supply vessel 208 contains refrigerant at full capacity or at another predetermined level). For example, when the system 200 is in the second operational mode and has completed replenishing the supply of refrigerant within the supply vessel 208, if the supply vessel 208 is not full, the pressure within the supply vessel 208 can be less than the threshold pressure causing the pressure-regulated valve 226 to open until the supply vessel 208 is refilled by the influx of refrigerant from the make-up reservoir 220.

FIG. 3 is an enlarged, partially schematic diagram illustrating the recompression unit 110 along with adjacent portions of the high-pressure line 206 and the low-pressure line 210. The recompression unit 110 can be configured to increase the pressure of refrigerant from the low-pressure line 210 to the high-pressure line 206. In some cases, refrigerant within the high-pressure line 206 downstream from recompression unit 110 can be at a treatment pressure (e.g., a cryo-treatment pressure sufficient for cryogenic alteration of tissue). For example, the recompression unit 110 can be configured to increase the pressure of refrigerant from the low-pressure line 210 to a treatment pressure of about 700 psi to about 900 psi in the high-pressure line 206 when the recompression unit 110 is configured for use with room-temperature nitrous oxide. As another example, the recompression unit 110 can be configured to increase the pressure of refrigerant from the low-pressure line 210 to a treatment pressure of about 300 psi to about 500 psi in the high-pressure line 206 when the recompression unit 110 is configured for use with chilled nitrous oxide. As yet another example, the recompression unit 110 can be configured to increase the pressure of refrigerant from the low-pressure line 210 to a treatment pressure of about 200 psi to about 300 psi in the high-pressure line 206 when the recompression unit 110 is configured for use with a hydrofluorocarbon refrigerant.

In some embodiments, the recompression unit 110 is configured to at least partially condense refrigerant moving through the recompression unit 110. The recompression unit 110 can include a first pump 300, a second pump 302, and a condenser 304 therebetween. The first pump 300 can be configured to pump gaseous refrigerant. For example, the first pump 300 can be configured to draw exhausted refrigerant into the recompression unit 110 and/or to raise the pressure of exhausted refrigerant to a pressure slightly below the saturation pressure of the type of refrigerant at room temperature or at an operating temperature of the recompression unit 110. The condenser 304 can be configured to at least partially condense refrigerant downstream from the first pump 300 (e.g., by extracting heat from refrigerant passing through the condenser 304). The second pump 302 can be a condensate pump configured to pump liquid refrigerant. For example, the second pump 302 can be configured to pressurize condensed refrigerant exiting the condenser 304 to at least a treatment pressure and to control the flow of refrigerant away from the recompression unit 110. In some cases, the second pump 302 can be a positive displacement pump configured to prevent backflow through the recompression unit 110.

Many variations of the

recompression units

110, 400 are possible in accordance with embodiments of the present technology. For example, the first pump 300, the second pump 302, and/or the condenser 304 individually can include one or more stages. In some embodiments, the first pump 300, the second pump 302, and the condenser 304 have another suitable order within the recompression unit 110. Furthermore, the first pump 300, the second pump 302, or the condenser 304 can be eliminated. FIG. 4 is an enlarged, partially schematic diagram illustrating a recompression unit 400 including the condenser 304 and the second pump 302 without the first pump 300. FIG. 5 is an enlarged, partially schematic diagram illustrating a recompression unit 500 including the first pump 302 and the condenser 304 without the second pump 302. FIG. 6 is an enlarged, partially schematic diagram illustrating a recompression unit 600 including the condenser 304, a first-stage pump 602 upstream from the condenser 304, and a second-stage pump 604 between the condenser 304 and the first-stage pump 602. In the

recompression units

500, 600, the first pump 300, the first-stage pump 602, and the second-stage pump 604 can be configured to pump gaseous refrigerant.

FIG. 7 is an enlarged, partially schematic diagram illustrating a recompression unit 700 that is not configured to condense refrigerant. The recompression unit 700 can include the first-stage pump 602 and the second-stage pump 604 downstream from the first-stage pump 602. In other embodiments, the recompression unit 700 can be configured for only one refrigerant recompression stage or for more than two refrigerant recompression stages. With reference to FIGS. 3-7 together, the

recompression units

110, 400, 500, 600, 700 can be configured to increase the pressure of refrigerant moving from the low-pressure line 210 to the high-pressure line 206 by a ratio from about 1:5 to about 1:75 (e.g., a ratio from about 1:10 to about 1:50). In some embodiments, the

recompression units

110, 400, 500, 600, 700 are configured to increase the pressure of refrigerant moving from the low-pressure line 210 to the high-pressure line 206 by a ratio of at least 1:30 (e.g., at least 1:50).

FIG. 8 is an enlarged, partially schematic diagram illustrating the exhaust vessel 212 (FIG. 2), which can be a fixed-volume tank. In other embodiments, the exhaust vessel 212 can be expandable, which can reduce the presence of air within the exhaust vessel 212 and/or other refrigerant-carrying component of the system 200. For example, FIG. 9 is a enlarged, partially schematic diagram illustrating an exhaust vessel 900 including a cylinder 902, a piston 904 within the cylinder 902, and a biasing member 906 configured to resiliently retract the piston 904 when refrigerant is introduced into the exhaust vessel 900. As another example, FIG. 10 is an enlarged, partially schematic diagram illustrating an exhaust vessel 1000 that is an inflatable bladder, which can be configured to expand compliantly, non-compliantly, or semi-compliantly when refrigerant is introduced into the exhaust vessel 1000. With reference to FIG. 2, expanding the exhaust vessel 212 can facilitate temporary storage of refrigerant upstream from the recompression unit 110 (e.g., before activating the recompression unit 110 during the second operational mode). In some embodiments, the supply vessel 208 is expandable in addition to or instead of the exhaust vessel 212 being expandable. For example, the supply vessel 208 can have one of the forms described above with reference to FIGS. 9 and 10.

FIG. 11 is a block diagram illustrating stages during operation of the system 200 in accordance with an embodiment of the present technology. The stages can occur simultaneously (e.g., during steady-state operation of the system 200) or non-simultaneously (e.g., during start-up and/or shut-down of the system 200). With reference to FIGS. 2, 3 and 11 together, at a first stage 1100, a volume of refrigerant within the system 200 can be contained in the exhaust vessel 212 as a gas at a relatively low pressure (e.g., a pressure slightly above atmospheric pressure). At a second stage 1102, the first pump 300 can pressurize the refrigerant (e.g., to a pressure slightly below its saturation pressure at room temperature). At a third stage 1104, the condenser 304 can cool the refrigerant to a temperature below its condensation temperature. This cooling can cause the refrigerant to condense into a liquid. At a fourth stage 1106, the second pump 302 can pump the refrigerant to a pressure high enough to maintain circulation through the system 200.

At a fifth stage 1108, the refrigerant can be contained in the supply vessel 208 as a liquid at a relatively high pressure. In some cases, make-up refrigerant can be added to the supply vessel 208 to replace any refrigerant loss from the system 200. At a sixth stage 1110, the refrigerant can travel through the supply lumen 112 to the expansion orifice 130. The pressure of the refrigerant within the supply vessel 208 can be sufficiently high to generally maintain the refrigerant in liquid phase while it travels to the expansion orifice 130. At a seventh stage 1112, the refrigerant can travel through the expansion orifice 130 and into the cooling chamber 128. A sharp drop in pressure at the expansion orifice 130 can cause the refrigerant to vaporize, which can cool the cooling chamber 128 primarily due to the refrigerant absorbing its latent heat of vaporization. At an eighth stage 1114, the refrigerant in gaseous phase can exit the cooling chamber 128 via the exhaust opening 132. At a ninth stage 1116, the refrigerant can travel though the exhaust lumen 114 to the exhaust vessel 212. The refrigerant can then repeat the process beginning with the first stage 1100 if the system 200 is still in use or remain in the exhaust vessel 212 until the system 200 is restarted.

This disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein. Although specific embodiments of the present technology are disclosed herein for illustrative purposes, various equivalent modifications are possible without deviating from the present technology, as those of ordinary skill in the relevant art will recognize. In some cases, well-known structures and/or functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, alternative embodiments may perform the steps in a different order. Similarly, certain aspects of the present technology disclosed in the context of particular embodiments can be combined or eliminated in other embodiments. While advantages associated with certain embodiments of the present technology may have been disclosed in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present technology. This disclosure and the associated technology encompass a wide variety of other embodiments not expressly shown or described herein.

Certain aspects of the present technology may take the form of computer-executable instructions, including routines executed by a controller or other data processor. In some embodiments, a controller or other data processor is specifically programmed, configured, or constructed to perform one or more of these computer-executable instructions. Furthermore, some aspects of the present technology may take the form of data (e.g., non-transitory data) stored or distributed on computer-readable media, including magnetic or optically readable or removable computer discs as well as media distributed electronically over networks. Data structures and transmissions of data particular to aspects of the present technology are encompassed within the scope of the present technology. The present technology also encompasses methods of both programming computer-readable media to perform particular steps and executing the steps.

Throughout this disclosure, the singular terms “a,” “an,” and “the” include plural referents unless the context clearly indicates otherwise. Similarly, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the terms “including,” “comprising” and the like are used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. Directional terms, such as “upper,” “lower,” “front,” “back,” “vertical,” and “horizontal,” may be used herein to express and clarify the relationship between various structures. It should be understood that such terms do not denote absolute orientation. Reference herein to “one embodiment,” “an embodiment,” or similar formulations means that a particular feature, component, or operation described in connection with the embodiment can be included in at least one embodiment of the present technology. Thus, the appearances of such phrases or formulations herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, components, and/or operations may be combined in any suitable manner based on this disclosure.

Claims

We claim:

1. A cryotherapeutic system, comprising:

a high-pressure line configured to be removably connected to a supply lumen of a cryo-catheter;

a low-pressure line configured to be removably connected to an exhaust lumen of the cryo-catheter;

a recompression unit operably connected to the high-pressure line and the low-pressure line, the recompression unit being configured to increase the pressure of and at least partially condense refrigerant moving from the low-pressure line to the high-pressure line, wherein the high-pressure line, the low-pressure line, and the recompression unit are configured to contain a first volume of refrigerant; and

a make-up reservoir configured to contain a second volume of refrigerant sufficient to replace refrigerant loss from the first volume of refrigerant caused by disconnecting the supply lumen from the high-pressure line, disconnecting the exhaust lumen from the low-pressure line, or both,

wherein the high-pressure line, the low-pressure line, and the recompression unit are configured to define a portion of a closed loop when the high-pressure line is operably connected to the supply lumen and the low-pressure line is operably connected to the exhaust lumen.

2. The system of claim 1, wherein the make-up reservoir is removably connectable to the high-pressure line, the low-pressure line, or both.

3. The system of claim 1, further comprising the cryo-catheter, wherein the cryo-catheter includes:

a shaft within which the supply lumen and the exhaust lumen are disposed; and

a cryo-applicator attached to the shaft, the cryo-applicator having a cooling chamber configured to receive refrigerant from the high-pressure line via the supply lumen and to return refrigerant to the low-pressure line via the exhaust lumen.

4. The system of claim 3, wherein the cryo-catheter is disposable.

5. A cryotherapeutic system, comprising:

a high-pressure line configured to be removably connected to a supply lumen of a cryo-catheter, the high-pressure line including a supply vessel configured to contain liquid refrigerant;

a low-pressure line configured to be removably connected to an exhaust lumen of the cryo-catheter, the low-pressure line including an exhaust vessel configured to contain gaseous refrigerant; and

a recompression unit operably connected to the high-pressure line and the low-pressure line, the recompression unit being configured to increase the pressure of and at least partially condense refrigerant moving from the low-pressure line to the high-pressure line,

6. The system of claim 5, wherein the exhaust vessel is expandable.

7. The system of claim 5, wherein:

the system has a first operational mode and a non-concurrent second operational mode;

the system is configured to at least partially deplete a supply of refrigerant within the supply vessel by supplying refrigerant from the supply vessel to the supply lumen when the high-pressure line is operably connected to the supply lumen and the system is in the first operational mode; and

the system is configured to at least partially replenish the supply of refrigerant within the supply vessel with refrigerant from the exhaust vessel while the system is in the second operational mode.

8. The system of claim 7, wherein:

the high-pressure line, the low-pressure line, and the recompression unit are configured to contain a first volume of refrigerant; and

the system further comprises—

a make-up reservoir configured to contain a second volume of refrigerant sufficient to replace refrigerant loss from the first volume of refrigerant caused by disconnecting the supply lumen from the high-pressure line, disconnecting the exhaust lumen from the low-pressure line, or both, and

a make-up valve operably connected to the make-up reservoir, the make-up valve configured to regulate movement of refrigerant from the second volume of refrigerant toward the first volume of refrigerant.

9. The system of claim 8, further comprising:

a pressure sensor, a volume sensor, or both configured to detect refrigerant loss from the first volume of refrigerant; and

a controller configured to receive an indication of refrigerant loss from the pressure sensor, the volume sensor, or both, and to open the make-up valve in response to the indication.

10. The system of claim 8, wherein:

the make-up reservoir and the make-up valve are operably connected to the high-pressure line;

the make-up valve is a pressure-regulated valve configured to automatically open when a pressure within a portion of the high-pressure line downstream from the pressure-regulated valve is less than a threshold pressure; and

the system further comprises a shutoff valve operably connected to the make-up reservoir and the high-pressure line.

11. The system of claim 10, further comprising a controller configured to open the shutoff valve after the system at least partially replenishes the supply of refrigerant within the supply vessel with refrigerant from the exhaust vessel while the system is in the second operational mode.

12. The system of claim 10, wherein the threshold pressure is selected to be at or near a pressure within the supply vessel when the supply vessel is full of refrigerant.

13. The system of claim 5, further comprising the cryo-catheter, wherein the cryo-catheter includes:

a shaft within which the supply lumen and the exhaust lumen are disposed; and

14. The system of claim 5, wherein the recompression unit is a single-stage pump configured to increase the pressure of refrigerant from the low-pressure line to the high-pressure line by a ratio of at least 1:50.

15. The system of claim 5, wherein the recompression unit is a multi-stage pump configured to increase the pressure of refrigerant from the low-pressure line to the high-pressure line by a ratio of at least 1:50.

16. The system of claim 1, wherein the cryo-catheter is disposable.

17. The system of claim 5, further comprising a reservoir fluidically coupled to the high-pressure line, the low-pressure line, the recompression unit, or a combination thereof, wherein the high-pressure line, the low-pressure line, and the recompression unit are configured to contain a first volume of refrigerant, and the reservoir is configured to contain a second volume of refrigerant sufficient to replace refrigerant loss from the first volume of refrigerant.

18. The system of claim 17, further comprising a controller operably coupled to the reservoir, wherein the controller includes instructions to inject refrigerant from the second volume of refrigerant in the reservoir to the first volume of refrigerant.

19. The system of claim 5, further comprising a filter fluidically coupled to the high-pressure line, the low-pressure line, the recompression unit, or a combination thereof, wherein the filter is configured to remove moisture, particulates, or both from refrigerant within the system.

20. The system of claim 5, wherein the recompression unit is configured to increase the pressure of refrigerant moving from the low-pressure line to the high-pressure line by a ratio from about 1:5 to about 1:75.

21. The system of claim 5, wherein the recompression unit includes a condenser and a positive displacement pump downstream from the condenser.

22. The system of claim 5, wherein:

the high-pressure line includes a supply valve configured to change the flow of refrigerant toward the supply lumen;

the low-pressure line includes an exhaust valve configured to change the flow of refrigerant toward the recompression unit; and

the system further comprises a controller operably connected to the exhaust valve and the supply valve.

23. The system of claim 5, wherein the portion of the closed loop is generally impermeable to moisture.

24. The system of claim 5, wherein:

the high-pressure line includes a first coupler valve configured to automatically open when the high-pressure line is operably connected to the supply lumen and to automatically close when the high-pressure line is not operably connected to the supply lumen; and

the low-pressure line includes a second coupler valve configured to automatically open when the low-pressure line is operably connected to the exhaust lumen and to automatically close when the low-pressure line is not operably connected to the exhaust lumen.

25. The system of claim 5, further comprising a check valve within or downstream from the recompression unit, the check valve configured to reduce or prevent migration of refrigerant from the high-pressure line to the low-pressure line.